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EC number: 811-451-5 | CAS number: 1802140-94-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The oral LD50 of the read across substance was ≥2,000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 18, 2004 to April 29, 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted with read across substance according to OECD Guideline 423, EU Method B.1, EPA OPPTS 870.1100 and JMAFF Japanese test guidelines, 2000, in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Japanese test guidelines
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals
- Supplier: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: 9-12 weeks old.
- Fasting period: Food was withheld overnight (for a maximum of 20 h) prior to dosing and 3-4 h after dosing.
- Acclimatisation period: At least 5 d.
- Water: Free access to tap-water.
- Diet: Free access to standard pelleted laboratory animal diet.
Animal husbandry
- Animals per cage: 3 animals.
- Housing: Macrolon cages (type IV; height 18 cm) containing purified sawdust as bedding material.
- Diet supplier: Altromin (code VRF 1), Lage, Germany.
Environmental conditions
- Air changes: Approximately 15 air changes per h.
- Temperature: 21±3°C.
- Humidity: 30 - 70%.
- Photoperiod: 12 h artificial fluorescent light and 12 h darkness per d. - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Dosing method: Oral gavage, using a stainless steel stomach tube.
Dose preparation: The formulations (w/w) were prepared in vehicle (propylene glycol) 4 h prior to dosing. - Doses:
- 300, 2,000 mg/kg
- No. of animals per sex per dose:
- 3 females
- Control animals:
- not specified
- Details on study design:
- - Dosing: Initially, the test substance was administered by oral gavage to three female Wistar rats at 300 mg/kg bw. Further, in a stepwise procedure additional groups of females were dosed at 300, 2,000, and 2,000 mg/kg bw.
- Dose volume: 10 mL/kg
Frequency of observations:
- Mortality/viability- Twice daily
- Body weight: Days 1 (pre-administration), 8 and 15 and at death (if found dead after Day 1).
- Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored
- Necropsy: Animals were sacrificed by asphyxiation using a oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 animal died at dose level of 2,000 mg/kg bw administered at step 4.
- Clinical signs:
- At 300 mg/kg- Hunched posture and uncoordinated movements.
At 2,000 mg/kg- Hunched posture, uncoordinated movements, lethargy, chromodacryorrhoea (snout), piloerection, flat gait and salivation.
The surviving animals had recovered from the symptoms between Day 1 and 4. - Body weight:
- The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- Macroscopic post mortem examination of the animal that was found dead during the study revealed abnormalities in the stomach (hemorrhage of glandular mucosa).
Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of the substance was ≥2,000 mg/kg bw
- Executive summary:
A study was conducted to assess the acute oral toxicity of the read across substance (2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)) in female rats according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100, in compliance with GLP. Initially, the test substance was administered by oral gavage to three female Wistar rats at 300 mg/kg bw. Further, in a stepwise procedure additional groups of females were dosed at 300, 2,000 and 2,000 mg/kg bw. Treated animals were observed for mortality, clinical signs and body weight changes for 14 d and were then culled and subjected to gross pathological examination. In the rats treated at 300 mg/kg bw, clinical signs such as hunched posture and uncoordinated movements were recorded. The rats treated at 2,000 mg/kg bw showed clinical signs that included hunched posture, uncoordinated movements, lethargy, chromodacryorrhoea (snout), piloerection, flat gait and salivation. Surviving rats had recovered from the symptoms between Day 1 and 4. The mean body weight gain in the treated rats was normal. One animal of the dose level 2,000 mg/kg bw at Step 4 was found dead. Macroscopic examination of animal that was found dead revealed abnormalities in the stomach (hemorrhage of glandular mucosa). No abnormalities were found in other animals at termination. Based on the study results, the LD50 was determined to be ≥2,000 mg/kg bw (van Huygevoort AHBM, 2004).
Reference
Table 1: Incidence of mortality
Dose level |
Mortality |
300 mg/kg |
0/3 |
300 mg/kg |
0/3 |
2,000 mg/kg |
0/3 |
2,000 mg/kg |
1/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
A study was conducted to assess the acute oral toxicity of the read across substance (2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)) in female rats according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100, in compliance with GLP. Initially, the test substance was administered by oral gavage to three female Wistar rats at 300 mg/kg bw. Further, in a stepwise procedure additional groups of females were dosed at 300, 2,000 and 2,000 mg/kg bw. Treated animals were observed for mortality, clinical signs and body weight changes for 14 d and were then culled and subjected to gross pathological examination. In the rats treated at 300 mg/kg bw, clinical signs such as hunched posture and uncoordinated movements were recorded. The rats treated at 2,000 mg/kg bw showed clinical signs that included hunched posture, uncoordinated movements, lethargy, chromodacryorrhoea (snout), piloerection, flat gait and salivation. Surviving rats had recovered from the symptoms between Day 1 and 4.The mean body weight gain in the treated rats was normal. One animal of the dose level 2,000 mg/kg bw at Step 4 was found dead. Macroscopic examination of animal that was found dead revealed abnormalities in the stomach (hemorrhage of glandular mucosa). No abnormalities were found in other animals at termination. Based on the study results, the LD50 was determined to be ≥2,000 mg/kg bw (van Huygevoort AHBM, 2004).
Justification for selection of acute toxicity – oral endpoint
The study was conducted according to internationally accepted guidelines, in compliance with GLP.
Justification for classification or non-classification
Acute oral toxicity:
Based on the results of an acute oral toxicity study with the read across substance (2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)), the test substance does not need to be classified for this endpoint according to EU CLP criteria (EC 1272/2008).
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